In an exclusive interview with The Fly, ZyVersa Therapeutics’ (ZVSA) CEO Stephen Glover talked about the company, its pipeline, pandemic-related impacts, and much more.
SPAC DEAL: ZyVersa is a clinical stage specialty biopharmaceutical company with two licensed proprietary product platforms invented by research scientists at University of Miami Miller School of Medicine. Its focus is on renal and inflammatory diseases. The company went public last year via a SPAC merger.
"If you look at what's happened in the capital markets over the last 24 months, things have radically changed in the biotech sector. The IPO window is actually closed right now. Hopefully it will open up in the first half or the second half of the year, but it's still uncertain. In 2019, right before the COVID pandemic, we were actually in a traditional IPO crossover process. We pulled back and I started looking at different alternatives to get to where I think we deserve to be as a company -- the public market," CEO Stephen Glover explained to The Fly.
PIPELINE: The company’s lead candidate in its renal pipeline is a novel Phase 2a-ready cholesterol efflux mediator, VAR 200, for focal segmental glomerulosclerosis, or FSGS, an orphan renal disease. “The renal space is a huge, really evolving pandemic in the United States. And there hasn't been any innovation in the space for quite some time. So, what I was looking for with the University of Miami was to see what could be done in the space that could make a difference for the patients,” the executive said. "We worked with the FDA and we’re happy to say that we have an open IND to work on Phase 2. From an investor standpoint, that’s about a $13B market opportunity in a combination with orphan renal diseases and larger diseases. We think we have a really nice path forward here.”
For treatment of inflammatory diseases, ZyVersa sees itself as "well positioned in the inflammasome space with a highly differentiated monoclonal antibody that inhibits inflammasome ASC" – IC 100. Unlike NLRP3 inhibitors, which target only the NLRP3 inflammasome, by targeting ASC, IC 100 potentially inhibits twelve or more types of inflammasomes. This is expected to better control inflammation in numerous inflammatory diseases that are triggered by activation of more than one type of inflammasome. Likewise, by targeting ASC, IC 100 inhibits ASC specks which amplify and propagate inflammation in inflammatory diseases. IC 100 has strong indication expansion potential in a broad range of inflammatory diseases.
"We are finishing up our pre-clinical work. And it’s really interesting that in pre-clinical alone there has been already about $5B worth in M&A by major companies such as Merck [MRK], Roche [RHHBY], and Novartis [NVS]," Glover noted.
‘A LOT TO DO’ IN 2023: Noting that ZyVersa is a new public company, the CEO said they've “got a lot to do” in 2023. "We were pretty quiet as a private company, and now getting our story out and getting the capital markets and patients to understand what we're doing is really a significant effort for a small company. I think that’s going to be a key issue that we will be doing."
The executive also highlighted that ZyVersa will begin treating patients in its initial human experience with its VAR 200 in 2023. “That will give us our initial signals to see what the safety and efficacy look like in humans, allowing us as a public company to show progress to the investor community on a milestone basis. Towards the end of 2023, first quarter of 2024 we will see pretty significant data announcements. Off of that, we will move forward into our next stage of development in 2024. It’s an excitement year for us with a lot to do.”
Glover is "very happy" with the company’s progress so far on the inflammasome side. “We’re just completing the scale up of our monoclonal antibody IC100 into clinical material; that will be completed in February. That will allow us to move forward with our other two initiatives moving towards an IND being open. We will do our GLP toxicology work and that’s an important step for us. We’re anticipating the results of that study in the second half of the year and that is the last major regulatory hurdle for us to file and meet with the FDA on a pre-IND basis. Parallel to that are the indications we’re looking at. We’re going to do some additional indication experience work. I think it will be an interesting year."
COVID-RELATED IMPACT: Discussing COVID-related impacts with The Fly, ZyVersa’s CEO said it is “optimistic that most of that is behind us. It was one of the reasons why we slowed down our development programs. Now, we can move forward with the pre-clinical work and I do think that trial enrollment is now becoming more predictable. We’re seeing consistency now.”
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
